DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 10/21/2025 and 10/23/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Response to Arguments
Applicant’s claim amendments have overcome the previously presented claim objections and rejections under 35 U.S.C. 112(b).
Applicant’s arguments, see Remarks dated 11/17/2025, regarding the previously presented prior art rejections have been fully considered but they are not persuasive.
Applicant has argued that that coverslip disclosed by Nath does not anticipate the claimed coverslip because Applicant asserts “The coverslip of the instant claims are active contributors to the biological model of the biochip, and not static, inert components” (see p. 18 of Remarks). This is not found persuasive, because “the only exceptions to giving the words in a claim their ordinary and customary meaning in the art are (1) when the applicant acts as their own lexicographer; and (2) when the applicant disavows or disclaims the full scope of a claim term in the specification” (MPEP 2111.01). Neither of these seem to be the case in the instant application, and therefore the claim term “cover slip” is given its plain and ordinary meaning, and the Examiner asserts that the substrate layer 37 disclosed by Nath reads on the claimed cover slip as set forth in the prior Office Action. The feature of the coverslip being an “active contributor” to the biological model is not commensurate in scope with the current pending claims; nonetheless, the cover slip (37) disclosed by Nath bounds a biological chamber (Abstract, para. 47) (Fig. 2), and is therefore understood to serve the purpose of actively contributing to a biological model.
Applicant has argued that the membrane disclosed by Nath does not anticipate the claimed membrane; however, this is not found persuasive because the differences discussed by the Applicant (see p. 20 of Remarks) are not commensurate in scope with the current pending claims. It is noted that independent claim 1 merely requires at least one porous membrane configured to provide a mimetic cellular environment and Nath discloses such a porous membrane, as discussed in the prior Office Action.
Similarly, Applicant discusses numerous functional advantages of the claimed biochip (see p. 21 of Remarks); however, these features are not commensurate in scope with the current pending claims and therefore do not introduce a patentable distinction over the prior art.
The amendments to the claims (including claim 29 noted by Applicant, see p. 22 of Remarks) have necessitated a modified grounds of rejection, presented below.
Claim Objections
Claims 1, 18, and 27-28 are objected to because of the following informalities:
In claim 1 (third to last line), it is recommended to change “between the at least one chassis” to “within the at least one chassis” for consistency with the prior lines of the claim.
In claim 18, it is recommended to change “coverslip” (second to last line) to “cover slip” for consistency with the prior claims.
In claims 27 and 28, respectively, it is believed the claim wording should read “wherein the at least one microfluidic channel…is enclosed”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 8, 12-20, 22, 24-25, and 27-29 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 8 recites the limitation "the one or more cylindrical ductal scaffold" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. Claim 2, from which claim 8 depends, provides antecedent basis for “one or more cylindrical scaffolds” rather than a cylindrical ductal scaffold.
Claim 12 recites the limitation "the one or more cylindrical ductal scaffold" in line 3. There is insufficient antecedent basis for this limitation in the claim. Claim 2, from which claim 12 depends, provides antecedent basis for “one or more cylindrical scaffolds” rather than a cylindrical ductal scaffold.
Claim 13 recites the limitation "the one or more cylindrical ductal scaffold" in line 3. There is insufficient antecedent basis for this limitation in the claim. Claim 2, from which claim 13 depends, provides antecedent basis for “one or more cylindrical scaffolds” rather than a cylindrical ductal scaffold.
Claim 14 recites the limitation "the one or more cylindrical ductal scaffold" in line 3. There is insufficient antecedent basis for this limitation in the claim. Claim 2, from which claim 14 depends, provides antecedent basis for “one or more cylindrical scaffolds” rather than a cylindrical ductal scaffold.
Claim 14 recites the limitation “the porous one or more cylindrical ductal scaffold locations” in lines 3-4. There is insufficient antecedent basis for this limitation in the claim. Claim 2, from which claim 14 depends, does not provide antecedent basis for porous one or more cylindrical ductal scaffold locations.
Claim 15 recites the limitation "the ductal scaffold" in line 3. There is insufficient antecedent basis for this limitation in the claim. Claim 2, from which claim 15 depends, provides antecedent basis for “one or more cylindrical scaffolds” rather than a ductal scaffold.
Claim 15 recites the limitation "the walls of the porous one or more cylindrical ductal scaffold" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim. Claim 2, from which claim 15 depends, provides antecedent basis for “one or more cylindrical scaffolds” rather than walls of a porous cylindrical ductal scaffold.
Claim 16 recites the limitation "the one or more cylindrical ductal scaffold" in line 3. There is insufficient antecedent basis for this limitation in the claim. Claim 2, from which claim 15 depends, provides antecedent basis for “one or more cylindrical scaffolds” rather than a cylindrical ductal scaffold.
Claim 16 recites the limitation "the walls of the ductal scaffold" in line 4. There is insufficient antecedent basis for this limitation in the claim. Claim 2, from which claim 16 depends, provides antecedent basis for “one or more cylindrical scaffolds” rather than walls of a ductal scaffold.
Claim 19 recites the limitation "the one or more cylindrical ductal scaffold" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Claim 2, from which claim 19 depends, provides antecedent basis for “one or more cylindrical scaffolds” rather than a cylindrical ductal scaffold.
Claim 20 recites the limitation "the one or more cylindrical ductal scaffold" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Claim 2, from which claim 20 depends, provides antecedent basis for “one or more cylindrical scaffolds” rather than a cylindrical ductal scaffold.
Claim 22 recites the limitation "the one or more cylindrical ductal scaffold" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 2, from which claim 22 depends, provides antecedent basis for “one or more cylindrical scaffolds” rather than a cylindrical ductal scaffold.
Claim 24 recites the limitation "the ductal scaffold" in line 3. There is insufficient antecedent basis for this limitation in the claim. Claim 2, from which claim 24 ultimately depends, provides antecedent basis for “one or more cylindrical scaffolds” rather than a ductal scaffold.
Claim 24 recites the limitation "the channel" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim. It is unclear if “the channel” is referring to the at least one microfluidic channel (claims 1 and 24), the channel (line 5 of claim 1), or the at least one channel (line 10 of claim 1).
Claim 25 recites the limitation "the ductal scaffold" in line 3. There is insufficient antecedent basis for this limitation in the claim. Claim 2, from which claim 25 ultimately depends, provides antecedent basis for “one or more cylindrical scaffolds” rather than a ductal scaffold.
Claim 25 recites the limitation "the channel" in line 3. There is insufficient antecedent basis for this limitation in the claim. It is unclear if “the channel” is referring to the at least one microfluidic channel (claims 1 and 25), the channel (line 5 of claim 1), or the at least one channel (line 10 of claim 1).
Claim 27 recites the limitation "the internal and external compartment surrounding the one or more cylindrical ductal scaffold" (emphasis added) in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. Claim 13, from which claim 27 depends, provides antecedent basis for an external compartment but not that it surrounds any other device element.
Claim 29 recites the limitation "the one or more cylindrical ductal scaffold" in line 5. There is insufficient antecedent basis for this limitation in the claim. Claim 2, from which claim 29 depends, provides antecedent basis for “one or more cylindrical scaffolds” rather than a cylindrical ductal scaffold.
Dependent claims are rejected for the same reason(s) as the base claim(s) upon which they depend.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2, 4-30, and 32-36 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nath et al. (US Patent Application Publication 2018/0066220) (already of record).
Regarding claim 1, Nath et al. discloses a biochip (called microfluidic device, para. 3, has the form of a chip, see Fig. 2, sheet 2 of 15) for growing ductal tissue (the device is fully capable of growing ductal tissue, see para. 90-93), the biochip comprising:
at least one membrane structure (31) (called hollow fiber or HF, comprises a “tubular membrane”, see para. 40, 47), wherein the at least one membrane structure includes at least one porous membrane configured to provide a mimetic cellular environment (para. 29, 40);
at least one chassis (comprising device layers 33 and 36 which read on at least one chassis as the layers form a body of the device, see para. 47 and Fig. 2, sheet 2 of 15), wherein the at least one chassis includes:
a channel (34) configured to support the at least one membrane structure (31) (para. 47) (Fig. 2, sheet 2 of 15), and
at least one microfluidic channel (35) in fluid communication with the channel supporting the at least one membrane structure (para. 14, 47); and
at least one cover slip (37) (para. 47) (Fig. 2, sheet 2 of 15);
wherein the at least one chassis is configured such that an internal space is provided within the at least one chassis and capable of creating at least one channel within the at least one chassis (para. 47) (Fig. 2, sheet 2 of 15);
wherein the internal space created within the at least one chassis provides a compartment that is internal relative to a body of the at least one chassis but external relative to the at least one membrane structure (see channel 34, which is internal to a body of the at least one chassis formed by layers 33 and 36 but external relative to membrane 31, see para. 47 and Fig. 2, sheet 2 of 15); and
wherein a plurality of openings are provided on the at least one chassis to allow fluid to enter or exit the internal space created between the chassis that provides an external compartment relative to the at least one membrane structure created within the at least one chassis (para. 47).
Regarding claim 2, Nath et al. discloses wherein the at least one membrane structure is one or more cylindrical scaffolds (para. 29, 40, 47, 83) (Fig. 2, sheet 2 of 15).
Regarding claim 4, Nath et al. discloses wherein the at least one membrane structure is a synthetic or organic polymer (para. 45).
Regarding claim 5, Nath et al. discloses wherein the at least one membrane structure is capable of mimicking the in-vivo tissue conditions for different or same biological materials (para. 29-30).
Regarding claim 6, Nath et al. discloses wherein the at least one membrane structure is capable of providing an environment for a plurality of stromal tissue types (para. 29-30, 97).
Regarding claim 7, Nath et al. discloses wherein the at least one membrane structure is capable of providing an environment for the testing of a plurality of disease models (para. 29-30, 59).
Regarding claim 8, Nath et al. discloses wherein the at least one chassis contains features that hold the at least one membrane structure in position (para. 47) giving access to internal and external compartments of the one or more cylindrical scaffolds (para. 45-47).
Regarding claim 9, Nath et al. discloses wherein the biochip is configured to have biological components pumped into the at least one microfluidic channel of the biochip (para. 14, 47, 49).
Regarding claim 10, Nath et al. discloses wherein biological components are of a same type (e.g., multiple cells of a same type can be used in the device, see para. 10).
Regarding claim 11, Nath et al. discloses wherein biological components are different biological components (e.g., different cell types can be used in the device, see para. 10).
Regarding claim 12, Nath et al. discloses wherein the at least one chassis contains features forming one or more microfluidic channels giving access to internal and external compartments of the one or more cylindrical scaffolds (para. 14, 29, 45-47).
Regarding claim 13, Nath et al. discloses wherein the at least one chassis contains features forming the at least one microfluidic channel leading to internal and external compartments of the one or more cylindrical scaffolds (para. 14, 29, 45-47).
Regarding claim 14, Nath et al. discloses wherein the at least one chassis contains microfluidic channels leading to internal and external compartments of the one or more cylindrical scaffolds (para. 14, 29, 45-47) wherein these are interconnected at one or more areas of the at least one membrane structure (Fig. 2, sheet 2 of 15).
Regarding claim 15, Nath et al. discloses wherein the at least one chassis contains microfluidic channels leading to inner and external compartments of the at least one membrane structure that are interconnected (para. 14, 29, 45-47) (Fig. 2, sheet 2 of 15).
Regarding claim 16, Nath et al. discloses wherein the at least one chassis contains microfluidic channels leading to inner and external compartments of the at least one membrane structure that are interconnected (para. 14, 29, 45-47) (Fig. 2, sheet 2 of 15).
Regarding claim 17, Nath et al. discloses wherein the features are cut (reads on engraved) in one or more inner layers of the at least one chassis (para. 47) (Fig. 2, sheet 2 of 15).
Regarding claim 18, Nath et al. discloses wherein the features are cut (reads on engraved) on one or more outer surfaces of the at least one chassis and enclosed by the at least one coverslip creating a full channel (para. 47) (Fig. 2, sheet 2 of 15).
Regarding claim 19, Nath et al. discloses wherein a cross-section of the one or more cylindrical scaffolds is circular (Figs. 2 and 5A, sheets 2 and 5 of 15).
Regarding claim 20, Nath et al. discloses wherein the one or more cylindrical scaffolds are porous and wherein the pores can have various sizes and shapes (para. 45).
Regarding claim 21, Nath et al. discloses wherein some pores allow for the diffusion of biological components (para. 45).
Regarding claim 22, Nath et al. discloses wherein some pores allow for the migration of cells across a wall of the one or more cylindrical scaffolds (para. 45).
Regarding claim 23, Nath et al. discloses wherein the at least one chassis includes at least one inlet and at least one outlet holes (para. 47).
Regarding claim 24, Nath et al. discloses wherein the features extend between inlet and outlet holes of a channel (para. 14, 29, 45-47) (Fig. 2, sheet 2 of 15).
Regarding claim 25, Nath et al. discloses wherein the features extend beyond inlet and outlet holes of a channel (para. 14, 29, 45-47) (Fig. 2, sheet 2 of 15). As to the limitation of the features being later plugged post-assembly of sub-components of the biochip, this is a recitation of intended use of the device and has therefore been given appropriate patentable weight. The prior art meets this limitation as the features are fully capable of being plugged (see pluggable openings in Fig. 2, sheet 2 of 15).
Regarding claim 26, Nath et al. discloses wherein the at least one chassis is configured to be used with an imaging device (para. 46).
Regarding claim 27, Nath et al. discloses the at least one microfluidic channel allowing fluids to flow to internal and external compartments of the at least one membrane structure and enclosed in the at least one chassis (para. 14, 29, 46-47) (Fig. 2, sheet 2 of 15).
Regarding claim 28, Nath et al. discloses wherein the at least one microfluidic channel is enclosed between the at least one chassis and the at least one cover slip (para. 14, 29, 46-47) (Fig. 2, sheet 2 of 15) wherein the cover slip covers an additional side of the biochip not enclosed by the at least one chassis (Fig. 2, sheet 2 of 15).
Regarding claim 29, Nath et al. discloses wherein the at least one membrane structure is bonded to the at least one chassis (para. 47) and surrounded by a microfluidic channel void from all sides (Fig. 2, sheet 2 of 15) (furthermore, the device is fully capable of culturing stromal tissue types, see para. 29-30, 97, and thus the microfluidic channel void reads on stromal microfluidic channel void). As to the limitation of the at least one porous membrane being curved and bonded prior to assembly in an area on a surface of the one or more cylindrical scaffolds along its length, it is noted that the patentability of a product does not depend on its method of production (MPEP 2113), and therefore this limitation does not introduce a patentable distinction over the prior art, as the prior art at least one porous membrane is a cylindrical membrane as in the claim.
Regarding claim 30, Nath et al. discloses wherein the at least one chassis is made of a transparent material (Fig. 3, sheet 3 of 15) such as a polymer (para. 68).
Regarding claim 32, Nath et al. discloses wherein the at least one chassis is made of a polymeric material such as acrylic or polycarbonate (para. 68) and thus the at least one chassis reads on being configured to deform in response to a stimulus (e.g., either acrylic or polycarbonate would melt or “deform” in response to a sufficient heat stimulus). Nath et al. further discloses wherein the at least one membrane structure is encapsulated within the at least one chassis (para. 47) (Fig. 2, sheet 2 of 15).
Regarding claim 33, Nath et al. discloses wherein the stimulus is heat, as set forth in the rejection of claim 32, above.
Regarding claim 34, Nath et al. discloses wherein the at least one cover slip and the at least one chassis are integrated to form a unitary body (para. 47) (Fig. 2, sheet 2 of 15).
Regarding claim 35, Nath et al. discloses wherein the at least one cover slip is made of a material that is transparent (Fig. 3, sheet 3 of 15).
Regarding claim 36, the limitation of the biochip being capable of being connected to and interacting with a plurality of additional biochips is a recitation of intended use and has been given appropriate patentable weight. The device disclosed by Nath et al. comprising tubing for connecting to an external device (para. 47) (Fig. 2, sheet 2 of 15) and is thus structurally capable of achieving the claimed intended use (e.g., a user could connect multiple biochips in series via the tubing). Therefore, the prior art meets the claim.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Nath et al. (US Patent Application Publication 2018/0066220) (already of record) in view of Papenburg et al. (Development and analysis of multi-layer scaffolds for tissue engineering).
Regarding claim 3, Nath et al. discloses wherein the at least one membrane structure is one or more cylindrical scaffolds, as set forth above.
Nath et al. is silent as to wherein the at least one membrane structure is capable of being nested within an internal space within the one or more cylindrical scaffolds of the at least one membrane structure, providing layers of porous membrane ductal scaffolds nested within each other.
Papenburg et al. discloses a membrane structure comprising a porous membrane rolled up into a cylinder to provide layers of porous membrane structure nested within each other (Abstract, p. 6229 col. 2 para. 2, p. 6230 col. 1 para. 3-col. 2 para. 2) (Fig. 1). Papenburg et al. discloses that this configuration provides a more physiologically accurate cell culture model due to its multilayered nature (Abstract, p. 6220 col. 1 para. 3-col. 2 para. 1).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the at least one membrane structure disclosed by Nath et al. to have a rolled configuration, i.e., wherein the at least one membrane structure is capable of being nested within an internal space within the one or more cylindrical scaffolds of the at least one membrane structure, providing layers of porous membrane ductal scaffolds nested within each other, as Papenburg et al. discloses that it was known in the art to use such a rolled configuration to enhance the physiological accuracy of a cell culture device, and the skilled artisan would have been motivated to select a membrane configuration that enhances the experimental utility of the device.
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Nath et al. (US Patent Application Publication 2018/0066220) (already of record) in view of Saez et al. (US Patent Application Publication 2012/0231517) (already of record).
Regarding claim 31, Nath et al. discloses the at least one chassis, as set forth above, but is silent as to the at least one chassis being made of a material that is opaque.
Saez et al. discloses that it was known in the art to form a substrate of a microscale biological device from an opaque material to allow for analysis techniques such as fluorescence, luminescence, or colorimetric methods (para. 33).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to form the at least one chassis disclosed by Nath et al. to be made of a material that is opaque, based on the teachings of Saez et al., in order to allow for successful fluorescence, luminescence, and/or colorimetric analysis of biological material within the device, thereby enhancing the experimental utility of the device.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/HOLLY KIPOUROS/Primary Examiner, Art Unit 1799